Pessary with applicator

ABSTRACT

An intravaginal pessary device in an applicator is provided. The device has a top and a bottom, and a sidewall that extends between the top and the bottom. The sidewall, top and bottom form an outer periphery defining a total area of the device. The pessary device has a maximum diameter that is less than about 25 mm. The pessary device and applicator exhibit a maximum expulsion force that is below 1500 grams.

FIELD OF INVENTION

This application relates to pessary devices for relief of femaleincontinence. More particularly, the present invention relates topessary devices inserted with an applicator with improved ease havingdesirable expulsion characteristics

BACKGROUND OF THE INVENTION

Urinary incontinence, in which the ordinary bodily muscle functions failto prevent unintended leakage of urine, is a common malady among women,particularly older women. It is estimated that up to 50% of womenoccasionally leak urine involuntarily, and that approximately 25% ofwomen will seek medical advice at some point in order to deal with theproblem. Stress incontinence, the most common type of urinaryincontinence, refers to the involuntary loss of urine resulting fromabdominal pressure rise, occurring during exercise, coughing, sneezing,laughing, etc. When stress incontinence occurs, it is usually the resultof the abnormal descent of the urethra and bladder neck below the levelof the pelvic floor. Many women wear sanitary napkins or diapers inorder to deal with incontinence, and some women resort to surgicalprocedures.

Pessary devices are known to help relieve involuntary urination in afemale. Such devices are designed for arrangement in the vagina forcompressive action on and support of the bladder. Typical pessarydevices are large in diameter during use, and can elastically expand,inflate, or unfold to provide compressive action within the vagina. Suchpessary devices can be uncomfortable for a user and/or can require theuser to activate or operate the device prior to or upon insertion of thepessary device into the vagina. This can result in an undesirable usageexperience.

Further, the insertion process can pose additional obstacles. Somepessary devices require digital insertion into the body which may not bepreferred. A preferred insertion method for many consumers is via anapplicator. However, due to the size of the pessary needed to beeffective and the desire to have minimal applicator sizes, the insertionprocess can create an undesirable usage experience. Some pessaries canalso expand within an applicator increasing the force needed to expelthe pessary upon insertion. Depending on the user's dexterity and handstrength, this can be problematic for many of the consumers wishing touse the product.

As such, there remains a need for a pessary device which can be moreeasily inserted via an applicator and deliver improved comfort.

SUMMARY OF THE INVENTION

An intravaginal pessary device housed within an applicator is disclosed.The device having an outer periphery defining a total area of the deviceand a central longitudinal axis, the applicator comprises a barrelregion with a central longitudinal axis. The pessary device and theapplicator exhibit a maximum expulsion force below 1,500 grams-force.

A non-expandable intravaginal pessary device having an outer peripherydefining a total area of the device and an applicator having a barrelregion enabled to house the pessary device is disclosed. The pessarydevice outer periphery has a maximum outer diameter, the applicatorbarrel region has an inner diameter, and the pessary device andapplicator exhibit an expulsion force profile having a first peak below5 Newtons.

An intravaginal pessary device having an outer periphery defining atotal area of the device and an applicator having a barrel regionenabled to house the pessary device is also disclosed. The pessarydevice and applicator exhibit an expulsion force profile having a firstpeak below 5 Newtons and have a maximum expulsion force of less than1500 grams-force.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims particularly pointing outand distinctly claiming the subject matter of the present invention, itis believed that the invention can be more readily understood from thefollowing description taken in connection with the accompanyingdrawings, in which:

FIG. 1A is a side view of a pessary device;

FIG. 1B is a perspective view of the pessary device of FIG. 1A;

FIG. 2A is a side view of a pessary device;

FIG. 2B is a perspective view of the pessary device of FIG. 2B;

FIG. 3 is a side view of a pessary device;

FIG. 4 is a side view of a pessary applicator, housing the pessary ofFIG. 1;

FIG. 5 is a cross section view of FIG. 4 taken along 5-5;

FIG. 6 graphs the force profile to expel the claimed pessary device fromits applicator;

FIG. 7 graphs the force profile to expel a Tampax Ultra from itsapplicator;

FIG. 8 graphs the force profile to expel a commercial pessary from itsapplicator;

FIG. 9 shows a partial view of an applicator insertion end.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is directed to pessary devices that are insertedinto the female vagina with an applicator to help control involuntaryurinary incontinence. The pessary devices can be non-expandable orexpandable, small in size, easily insertable and can provide improvedcomfort during use. The pessary device's largest outer circumference canbe smaller than the inner circumference of an applicator interior or ofthe same dimension.

The pessary devices can include a convex portion adapted to extendbetween an anterior vaginal wall and a posterior vaginal wall of a userto provide pressure on the user's urethra through the vaginal wall. Theconvex portion includes the maximum diameter of the pessary, wherein themaximum diameter is less than 35 mm. The pessary device also can includea second convex portion provided distal from the first convex portion.In addition, the pessary device also can include a region that caninclude the minimum diameter of the pessary device. The combined pessarydevice and applicator exhibit desirable expulsion characteristicsincluding, but not limited to, expulsion force, force profile duringexpulsion, and work required to expel the pessary device from theapplicator.

As used herein, “applicator” refers to a device or implement thatfacilitates the insertion of the pessary device into an external orificeof a mammal. Exemplary applicators include telescoping, tube andplunger, and compact applicators.

The term “joined” or “attached” as used herein, encompassesconfigurations in which a first element is directly secured to a secondelement by affixing the first element directly to the second element,configurations in which the first element is indirectly secured to thesecond element by affixing the first element to intermediate member(s)which in turn are affixed to the second element, and configurations inwhich first element is integral with second element, i.e., first elementis essentially part of the second element.

As used herein, the term “non-expandable” refers to devices that do notexpand prior to or during use, such as, for example, devices that do notincrease in size or volume prior to or during use. For example,non-expandable devices have a diameter and/or volume that does notincrease. In contrast, “expandable” as used herein, refers to devicesthat do increase in size or volume prior to or during use, such as, forexample, devices that increase in diameter and/or length, absorb fluidinto a fibrous or absorbent gelling material structure, or otherwisechange from a first size or volume to a second size or volume, such as,for example, by inflation, absorption, mechanically, or by other means.Insubstantial changes to a non-expandable device as a result of anythermal expansion that could occur at body temperatures are notconsidered “expansion.”

A “pessary device” or more particularly an “incontinence pessary device”as used herein refers to devices specifically designed, configured,and/or adapted for placement into a vagina in order to reduce theoccurrence and/or severity of female urinary incontinence. A “pessarydevice” can include any type of substantially non-absorbent structurefor the purpose of reducing urine leakage and/or supporting a prolapseduterus and/or bladder. A pessary device does not include a menstrualtampon.

As used herein, the term “vaginal canal” refers to the internalgenitalia of the human female in the pudendal region of the body. Theterms “vaginal canal” or “within the vagina” as used herein are intendedto refer to the space located between the introitus of the vagina(sometimes referred to as the sphincter of the vagina) and the cervix.

An exemplary pessary device 10 is shown in FIGS. 1A and 1B. The pessarydevice 10 includes a top 20, a bottom 30, a mid-section 40, a convexportion 50 of the top 20, a convex portion 60 of the bottom 30, amaximum diameter D₁, a minimum diameter D₂, a sidewall 80 extending fromthe top 20 to the bottom 30, a longitudinal axis (L) and a transverseaxis (T). As shown in FIGS. 1A and 1B, the pessary device 10 can havesides 140 that include concave portions 150. The pessary device can besymmetric about the longitudinal axis, including for example, whereinthe base is circular and symmetric about the longitudinal axis. Theconvex bottom portion 60 can have a maximum diameter D₁ to provideconvex portion 50. In addition, concave portion 150 can have a minimumdiameter D₂ that is less than maximum diameter D₁.

FIGS. 2A and 2B show a pessary device 10. The pessary device 10 includesa top 20, a bottom 30, a mid-section 40, a convex portion 50 of the top20, a convex portion 60 of the bottom 30, a maximum diameter D₁, aminimum diameter D2, a sidewall 80 extending from the top 20 to thebottom 30, a longitudinal axis (L) and a transverse axis (T). As shownin FIGS. 2A and 2B, the pessary device 10 can have sides 140 thatinclude concave portions 150. The pessary device shown in FIGS. 2A and2B has an upper slope that is greater than the upper slope of thepessary device shown in FIGS. 1A and 1B. In addition, the pessary deviceshown in FIGS. 2A and 2B has a lower slope 90 that is greater than thelower slope 90 of the pessary device shown in FIGS. 1A and 1B.

The pessary device 10 can include an overwrap 300 and/or a withdrawalmember 310, such as, for example, as shown in FIG. 3. In addition, FIG.3 shows that withdrawal member 310 can be attached to overwrap 300.

The pessary device can be inserted using an applicator. FIG. 4 shows anapplicator 410 that includes an insertion member 420 and a plunger 440.The insertion member 420 has an insertion end 421 and a withdrawal end422 opposite the insertion end 421. The insertion member 420 also caninclude a barrel region 450 adapted to contain the pessary device, and agrip region 430 that can be an indentation region 424 provided oppositethe insertion end 421, such as, e.g., proximal to the withdrawal end422. The grip region 430 can include one or more grip elements 423.

The insertion end 421 can have one or more containing elements 426 tohold the pessary device within the applicator 410. A containing elementcan be in the form of a petal. A single petal can be used to hold thepessary device within the applicator until the user expels the pessarydevice. The insertion end can have between two and ten petals to holdthe pessary device within the applicator until the user expels thepessary device.

The expulsion force necessitated to expel an intravaginal device from anapplicator is equivalent to the sum of all the forces acting on thedevice. These forces can include the force needed to push through oropen a petal design at an insertion end of an applicator, a force equalto the weight of the device to offset the gravitational force, and africtional force arising from the normal force exerted by the device onthe walls of an applicator. The amount of normal force can also dependupon whether the pessary device expands within the applicator therebyincreasing the normal force or whether the normal force is created bythe contact between the outer perimeter of the pessary device and theinner walls of the applicator.

FIG. 5 shows a cross section of FIG. 4 taken along 5-5. The applicator410 barrel region 450 has an inner surface 452. As shown in FIG. 5, apessary device 10 is located within the applicator such that a gap 454is formed between the pessary device 10 and the applicator inner surface452 when the pessary device central longitudinal axis L is aligned withthe applicator central longitudinal axis L2. As shown in FIG. 5, whenthe barrel region is circular, the gap 454 is annular.

It is understood that an overwrap as shown in FIG. 3 could add to theexternal surface of the overall pessary device. As shown in FIG. 5, thepessary device can create an annular gap without the overwrap. However,depending on the size of the device, the overwrap can be included aspart of the pessary device while still having an annular gap between theapplicator barrel region inner surface and the pessary device.

A non-expanding pessary device may not change in size during the usageexperience, that is, the pessary device is the same size and diameterprior to insertion by the user as well as during use and removal. Forexample, the pessary device is not expandable or inflatable from itsoriginal size and the pessary device is not compressed for insertioninto the user's body, nor is the pessary device compressed forwithdrawal from the user's body. A portion or region of the pessarydevice can flex or be deformed, such as, for example, in the regionhaving the minimum diameter, but the pessary device does not expand andreturns to the original configuration after deformation. As such, thepessary device does not include any mechanical or other means thatrequires the user to change the size or shape of the pessary deviceduring use, such as, for example, before or after insertion or prior towithdrawal. This provides for a pessary device that has a size uponwithdrawal that is the same as the size during use, which can providefor improved comfort during use and withdrawal.

The pessary device can have a convex portion that has the maximumdiameter of the pessary, such as, for example, at the base or at thetop, that extends between the anterior vaginal wall and the posteriorvaginal wall of a consumer to provide pressure on the urethra throughthe vaginal wall. In addition, the pessary device can have a secondconvex portion having an increased diameter as compared to the minimumdiameter that can provide pressure on the urethra through the vaginalwall at a point distal from the first convex portion. The first convexportion and the second convex portion can be separated by any suitabledistance, such as, for example, by at least about 5 mm, at least about10 mm, at least about 15 mm, at least about 20 mm, at least about 25 mm,at least about 30 mm, at least about 35 mm, at least about 40 mm, atleast about 45 mm, at least about 50 mm, or any other suitable distance.

The pessary device can have any suitable number of convex portions,including for example, four or fewer convex portions, three or fewerconvex portions, two or fewer convex portions, one convex portion, orany other suitable number of convex portions.

The convex portion or portions can be any suitable shape, such as, forexample, a convex shape that provides pressure to the vaginal wall,including, for example, a lobe or other protuberance. The convex portionor regions can have a substantially circular cross-section. The pessarydevice also can include a minimum diameter region that can provideflexibility to the pessary device, such as, for example, by allowingbending or movement at the minimum diameter region. The minimum diameterregion can be any suitable shape, such as, for example, concave,indented, or the like, and can have any suitable cross-section, such as,for example, a substantially circular cross-section. The pessary devicecan include a concave region provided between two convex regions.

The pessary device can provide resistance to force when placed inside awoman's vagina. For example, when the pessary device is inserted intothe vagina, increases in abdominal pressure can act as a force on thepessary device through the vaginal wall. When the pessary device isdisposed in the vagina lengthwise, that is, with the top of the pessarydevice positioned toward the cervix, the bottom of the pessary devicepositioned toward the introitus, and the length of the pessary devicegenerally aligned with the length of the vagina, increases in abdominalpressure can act on the side of the pessary device, perpendicular to thelength of the pessary device. Of course, increases in abdominal pressurecan act on other regions of the pessary device, in addition oralternatively to acting on the side of the pessary device, including forexample, when the pessary device is inserted into the vagina in anorientation other than lengthwise.

Despite its small size, the pessary device can provide a resistance toforce of greater than about 10 psi, greater than about 15 psi, greaterthan about 20 psi, or greater than about 25 psi under about 2 newtons offorce. For example, the pessary device can provide a resistance to forceof greater than about 20 psi under about 2 newtons of force and greaterthan about 25 psi under about 3 newtons of force. The pessary devicealso can resist compression under pressure. For example, the pessarydevice can compress less than about 20% under about 2 newtons of force,less than about 15% under about 2 newtons of force, less than about 14%under about 2 newtons of force, less than about 13% under about 2newtons of force, less than about 12% under about 2 newtons of force,less than about 11% under about 2 newtons of force, less than about 10%under about 2 newtons of force, less than about 9% under about 2 newtonsof force, less than about 8% under about 2 newtons of force, less thanabout 7% under about 2 newtons of force, less than about 6% under about2 newtons of force, less than about 5% under about 2 newtons of force,less than about 4% under about 2 newtons of force, less than about 3%under about 2 newtons of force, less than about 2% under about 2 newtonsof force, or less than about 1% under about 2 newtons of force.

The pessary devices can provide a varied resistance to force along thelongitudinal axis of the pessary device. For example, the pessary devicecan provide a resistance to force that is greater at the maximumdiameter regions and smaller at the minimum diameter regions. Inaddition, the pessary device can compress differently along thelongitudinal axis at different regions. For example, when force isapplied to the side of the pessary, the minimum diameter region cancompress at least about 5% more than the maximum diameter region underthe same amount of pressure (for example, under about 200 g/m2 offorce), at least about 10% more than the maximum diameter region underthe same amount of pressure, at least about 15% more than the maximumdiameter region under the same amount of pressure, at least about 20%more than the maximum diameter region under the same amount of pressure,or at least 25% more than the maximum diameter region under the sameamount of pressure. Any suitable amount of force can be applied, suchas, for example, from about 200 g/m2 of force to about 1500 g/m2 offorce, from about 200 g/m2 of force to about 1400 g/m2 of force, fromabout 300 g/m2 of force to about 1200 g/m2 of force, or from about 400g/m2 of force to about 800 g/m2 of force.

The amount of resistance to force and the amount of compression underforce provided by the pessary device as a whole or provided by thedifferent regions of the pessary device can be measured in any suitablemanner. For example, one suitable method employs a Universal ConstantRate Elongation/Tensile Tester with computer interface (MTS, EdenPrairie, Minn.). The method measures the force required to compress thepessary device resting on its side at 0.8 mm at a rate of 20 mm per min.For this method, the load probe tip is 5 mm in diameter and the tip issemi-spherical in shape. In addition, the resting fixture is acylindrical steel plate 152 mm in diameter and 13 mm thick. The pessarydevice is placed on the steel table and the crosshead moves at 20mm/min. When a force of 2 grams is exhibited on the pessary device, thecrosshead automatically zeroes out and moves an additional 0.8 mm. Theprobe cycles back, and data is acquired at a rate of 100 Hz. This methodmeasures the peak force in grams versus the amount of compression in mm.For pessary devices having varying diameters or widths, such as, forexample, pessary devices having a maximum diameter or width and aminimum diameter or width, resistance to force at the different regionscan be measured using this method. For example, for a pessary device asshown in FIGS. 1A and 1B, resistance to force at the maximum diameterregions D1 and D3 can be measured using a steel plate that is larger insize than the pessary device as the resting fixture. Resistance to forceat the minimum diameter region D2 can be measured using a single rodthat contacts the minimum diameter region but not the maximum diameterregions.

Generally, the convex portion can be resistant such that the convexportion can provide pressure to the vaginal wall. The convex portion canprovide resistance under high stress pressures typical of the humanvagina, such as, for example, by providing a maximum pressure to theurethra through the vaginal wall greater than about 5 psi, such as, forexample, greater than about 10 psi, greater than about 15 psi, greaterthan about 20 psi, or greater than about 25 psi. In addition, thepressure region can provide a maximum urethral closure of greater thanabout 1.0 mm, such as, for example, greater than about 1.1 mm, greaterthan about 1.2 mm, greater than about 1.3 mm, greater than about 1.4 mm,such as, for example, greater than about 1.5 mm, greater than about 1.6mm, greater than about 1.7 mm, greater than about 1.8 mm, or greaterthan about 1.9 mm. In addition, or alternatively, the convex portion cancompress less than about 1 mm when measured under 0.5 psi when the forceis applied from one side of the convex portion to the opposite side ofthe convex portion at the region of maximum diameter in the directionperpendicular to the longitudinal axis.

Maximum pressure to the urethra and maximum urethral closure can bemeasured using any suitable method, such as, for example, by using thecomputational model described in U.S. Patent Appln. No. 2007/0027667.For example, a computation model simulating the human internal pelvicenvironment can be used. In certain embodiments, thirteen nodes on theurethra in the simulation that are both on the back wall toward thevagina and in the middle of the body on the sagittal plane can bechosen. The points should be spread even along the length of the urethrawith the first point at the bottom edge of the urethra and the lastpoint at the bladder neck. Node vs. time vs. Von Mises stress should beobtained using a suitable software program, such as, for example,LS-Prepost, for all chosen nodes. The data columns are then matched todetermine the y position vs. time vs. Von Mises stress. Generally, onlythe data that is at the simulation end point should be selected andy-position vs. Von Mises is then plotted.

The minimum diameter region, on the other hand, can be more flexiblethan and provides less resistance than the convex portion. Addition ofthe minimum diameter region can allow the pessary device to flex in thelongitudinal direction as well at the lateral direction. For example,the pessary device can compress more than about 1 cm when measured under0.5 psi when the force is applied from the top to the base along thelongitudinal axis. In addition, or alternatively, the minimum diameterregion can provide a bending region that facilitates the pessary devicebending from side to side.

The pessary device can be a unitary construction. For example, thepessary device can include a continuous outer shell that defines theentire exterior surface of the pessary device. The outer shell can besmooth or textured. The outer shell can be permeable to fluid, such as,for example, by the inclusion of holes, pores, or other suitableopenings. Alternatively, the outer shell can be impermeable to fluidsuch that fluid cannot enter the device. In addition, the pessary devicecan include an opening in the top and/or base. The pessary device caninclude an opening in the top and/or base and the outer shell is notpermeable to fluid such that fluid cannot enter the device exceptthrough the opening in the top and/or base.

Suitable pessary devices can be solid or can have a hollow interior. Forhollow devices, the pessary device can have an outer periphery defininga total area of the device and an inner periphery defining an open areaof the device. The open area can be any suitable size, such as, forexample, between about 5% to about 95% of the total area, such as, forexample, from about 10% to about 90% of the total area, from about 15%to about 85% of the total area, or from about 20% to about 80% of thetotal area. In addition, the pessary device also can have a wallthickness that is suitable to maintain the pessary configuration. Thewall thickness can be greater than about 1 mm, such as for example,about 2 mm, about 3 mm, about 4 mm, about 5 mm, or greater. The wallthickness can be constant or varied along the length of the pessarydevice and/or around the circumference of the pessary device.

The pessary device can have any suitable shape having a varied diameteralong the longitudinal axis, such as, for example, a shape having avaried diameter that is symmetrical with respect to the longitudinalaxis, such as, for example, a teardrop, an apple, a pear, an hourglass,a waisted cylinder, a figure-8 shape, a peanut shape, a heart-shape, alight bulb shape, a bottle shape, a vase shape, or any other suitableshape. In addition, the shape can have a varied diameter and can besymmetrical with respect to both the longitudinal and lateral axis, suchas, for example, an hourglass, a waisted cylinder, a figure-8 shape, apeanut shape, or any other suitable shape. Alternatively, the pessarydevice can have an asymmetrical shape, such as, for example, a B-shapeor a P-shape. The pessary device can be symmetrical at one region andasymmetrical at another region, such as, for example, where the pessarydevice has a symmetrical pressure region and an asymmetrical flexileregion. Generally, the pessary device can have a varying diameter thatcan provide varying pressure along the user's urethra. For example, thepessary device can have a maximum diameter region that can correspond tothe convex portion. In addition, the pessary device can have a minimumdiameter region that can be a concave region.

The pessary device can be hourglass shaped. For example, as shown inFIGS. 1-2, the pessary device can have upper and lower portions joinedtogether by a waistline portion, with the upper and lower portionshaving diameters that are both greater than a diameter of the waistlineportion such that the pessary device has a generally hourglassconfiguration. In this configuration, the upper portion of the pessarydevice can have a top and the lower portion of the pessary device canhave a base, and the pessary device can have sloping upper and lowerwall sections joining the top and the base with the waistline portion.In addition, the waistline portion can include the minimum diameter ofthe pessary device. The upper and lower portions can have generallycoequal maximum diameters, or the upper and lower portions can havedifferent maximum diameters, such as, for example, where the upperportion has a maximum diameter greater than the lower portion or wherethe lower portion has a maximum diameter greater than the upper portion.

Generally, the pessary device includes at least one maximum diameter andat least one minimum diameter, where the minimum diameter is smallerthan the maximum diameter. The pessary device can include a firstportion having a maximum diameter, a second portion having a maximumdiameter, and a third portion that has a minimum diameter. The maximumdiameter of the first portion and the maximum diameter of the secondportion can be separated by a distance that is greater than about 10% ofthe length of the pessary device, such as, for example, by a distancegreater than about 5 mm, greater than about 10 mm, greater than about 15mm, greater than about 20 mm, greater than about 25 mm, greater thanabout 30 mm, greater than about 35 mm, greater than about 40 mm, greaterthan about 45 mm, or more. The pessary device can provide pressure atmid-urethra, the bladder neck, or both. In addition, the pessary devicecan provide higher pressure at the mid-urethra, the bladder neck, orboth and provides lower pressure at the area between the mid-urethra andthe bladder neck. For example, the pressure region can provide pressureat levels about 25% higher than the pressure provided by the flexileregion, such as, for example, at levels about 30% higher, about 35%higher, about 40% higher, about 45% higher, about 50% higher, about 55%higher, about 60% higher, or more.

The pessary device can have a slope from the maximum diameter to theminimum diameter. Any suitable slope can be used, including for example,about 0.25 mm, about 0.5 mm, about 0.75 mm, about 1 mm, about 1.5 mm,about 2 mm, about 2.5 mm, about 3 mm, about 4 mm, about 5 mm, about 6mm, about 7 mm, about 8 mm, or more, such as, for example, a slope fromabout 0.25 mm to about 5 mm, or a slope from about 0.5 mm to about 4 mm,or any other suitable range.

The slope of the pessary device from the minimum diameter to the maximumdiameter needs to be considered when combining with an applicator forexpulsion. If the shape of the transition deviates too far from theangle of the petals at the insertion end, a force spike may result whichcan hinder the insertion process. The slope of the transition shouldtherefore not deviate from the slope of the petal by more than 40%, suchas between 0% and 40%, such as for example, 5%, 10%, 15%, 20%, 25%, 30%,or 35%.

Suitable pessary devices are typically smaller in size than conventionalpessary devices. For example, the pessary devices have a maximumdiameter, a length, and/or a volume that is smaller or less than that ofconventional pessary devices.

The pessary devices can have any suitable maximum diameter, such as, forexample, a maximum diameter of less than 35 mm, such as, for example,less than 34 mm, less than 33 mm, less than 32 mm, less than 31 mm, lessthan 30 mm, less than 29 mm, less than 28 mm, less than 27 mm, less than26 mm, less than 25 mm, less than 24 mm, less than 23 mm, less than 22mm, less than 21 mm, less than 20 mm, less than 19 mm, less than 18 mm,less than 17 mm, less than 16 mm, less than 15 mm, less than 14 mm, lessthan 13 mm, less than 12 mm, less than 11 mm, or less than 10 mm,including, for example, a maximum diameter of from about 10 mm to about35 mm, from about 10 mm to about 25 mm, from about 13 mm to about 25 mm,or from about 15 mm to about 22 mm. The maximum diameter or width istypically measured at the widest portion of the pessary devicesubstantially perpendicular to the longitudinal axis.

The pessary devices can have any suitable minimum diameter that issmaller than the maximum diameter, including, for example, a minimumdiameter from about 40% to about 95% of the maximum diameter, from about40% to about 90% of the maximum diameter, from about 40% to about 85% ofthe maximum diameter, from about 40% to about 80% of the maximumdiameter, from about 45% to about 75% of the maximum diameter, or fromabout 50% to about 70% of the maximum diameter, such as, for example,about 45% of the maximum diameter, about 50% of the maximum diameter,about 55% of the maximum diameter, about 60% of the maximum diameter,about 65% of the maximum diameter, or about 70% of the maximum diameter.

The pessary devices can have a minimum diameter from about 4 mm to about28 mm, about 5 mm to about 20 mm, about 8 mm to about 20 mm, from about8 mm to about 18 mm, or from about 8 mm to about 15 mm, such as, forexample, about 8 mm, about 8.5 mm, about 9 mm, about 9.5 mm, about 10mm, about 10.5 mm, about 11 mm, about 11.5 mm, about 12 mm, about 12.5mm, about 13 mm, about 13.5 mm, about 14 mm, about 14.5 mm, about 15 mm,about 15.5 mm, about 16 mm, about 16.5 mm, about 17 mm, about 17.5 mm,about 18 mm, about 18.5 mm, about 19 mm, about 19.5 mm, or about 20 mm,or any other suitable minimum diameter. The minimum diameter or width istypically measured at the narrowest portion of the pessary devicesubstantially perpendicular to the longitudinal axis.

The maximum diameter and the minimum diameter can be separated by anysuitable distance, such as, for example, by about 5 mm, about 10 mm,about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about40 mm, about 45 mm, about 50 mm, or any other suitable distance.

The pessary devices can have any suitable length, such as, for example,a length from about 35 mm to about 60 mm, about 40 mm to about 55 mm, orabout 40 mm to about 50 mm, such as, for example, a length about 35 mm,about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm,about 47 mm, about 48 mm, about 49 mm, or about 50 mm. The length istypically measured substantially parallel to the longitudinal axis ofthe pessary device.

Generally, the pessary device can have a weight of less than about 10grams, less than about 9 grams, less than about 8 grams, less than about7 grams, less than about 6 grams, less than about 5 grams, less thanabout 4 grams, less than about 3 grams, less than about 2 grams, orabout 1 gram, including for example, a weight of from about 1 gram toabout 7 grams, or from about 2 grams to about 6 grams, or from about 1grams to about 4 grams, or from about 3 grams to 5 grams

Pessary devices can be fabricated using any suitable materials andmethods. For example, pessaries can be formed from polymeric materials,such as, for example, polycarbonate, polyester, polyethylene,polyacrylamide, polyformaldehyde, polymethylmethacrylate, polypropylene,polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride,polyurethane, nylon, silicone, or mixtures or blends thereof, ormetallic materials. In certain embodiments, the pessary devices are notformed from absorbent material such as, for example, fibrous material orabsorbent foam.

Pessary devices can be formed in any suitable manner, such as, forexample, using injection molding or other suitable methods of formingthe pessary device.

The pessary device can be covered by an overwrap. The overwrap can benon-absorbent or absorbent and can include any suitable material, suchas, for example, a fibrous nonwoven material comprising natural,synthetic, or a blend of natural and synthetic fibers. Suitablesynthetic fibers can include, e.g., fibers such as polyester,polyolefin, nylon, polypropylene, polyethylene, polyacrylic, celluloseacetate, polyhydroxyalkanoates, aliphatic ester polycondensates,bicomponent fibers and/or mixtures thereof. Natural fibers can include,e.g., rayon and those commonly known to be non-synthetic and of naturalorigin such as cotton. The fibers can have any suitable cross-sectionalshape, such as, e.g., round, tri-lobal, multi-lobal, delta, hollow,ribbon-shaped, and/or any other suitable shape, or mixtures thereof.Fibers with any suitable diameter can be used, such as, e.g., from about0.5 to about 50 microns, such as, e.g., from about 1 to about 30microns, such as, e.g., from about 10 to about 25 microns. Fiberdiameter can be determined using any suitable means; however, fornon-round fibers, diameter can typically be determined by reference tothe diameter of a fiber with the same cross-sectional area as thenon-round fiber.

The overwrap can be made by any number of suitable techniques and canhave any suitable basis weight. Suitable techniques include, forexample, carding, meltblowing, spunbonding, spunlacing, air laying, andthe like. For example, the overwrap can be formed using bonding methods,such as, e.g., thermal, ultrasonic, resin, through-air bonding,hydroentangling, and/or needling. The basis weight of the overwrap canbe any suitable weight, such as, e.g., from about 10 to about 60 gramsper square meter (gsm), such as, e.g., from about 15 to about 30 gsm. Inaddition, the overwrap can be hydrophilic or hydrophobic.

The overwrap can be joined to the pessary device by any variety ofmeans. The overwrap can be joined to itself or to the pessary device.For example, one portion of overwrap can be joined to an opposed portionof the overwrap or to the pessary device using any suitable adhesive orheat pressure bonding means. Such adhesive can extend continuously alongthe length of attachment or it can be applied in a non-continuousfashion at discrete intervals. Heat bonding includes thermally bonding,fusion bonding, or any other suitable means for joining such materials.

Pessary devices can also include lubricants applied to the overwrapmaterial to reduce the frictional force within the applicator uponinsertion. These ingredients serve to reduce the coefficient of frictionthereby lowering the frictional force when the normal force of thepessary device acting on the applicator walls cannot be reduced enough.Lubricants may be water based or oil based. Some examples may includeglycerin, mineral oil, petroleum jelly, silicone or water.

The pessary device can include a withdrawal member that can comprise anysuitable material, including for example, cotton, cellulose, rayon,polyolefins such as, for example, polyethylene or polypropylene, nylon,silk, polytetrafluoroethylene, wax, or any other suitable materials.

The withdrawal member can be formed by any suitable formation method andin any suitable configuration, such as, e.g., one or more cords,strings, finger covers, ribbons, an extension of a material of thedevice, or combinations thereof.

The pessary device is inserted using an applicator that can include aninsertion member and a plunger. The insertion member can have aninsertion end and a withdrawal end opposite the insertion end. Theinsertion member also can include a barrel region adapted to contain thepessary device, and a grip region that can be an indentation regionprovided opposite the insertion end, such as, e.g., proximal to thewithdrawal end.

The barrel region diameter can be larger than the largest pessarydiameter such that a gap is created between the barrel region innersurface and the pessary device outer surface when the pessary device isaligned along the central longitudinal axis of the applicator barrelregion. When the barrel region is in the form of a circle, the gap isannular. When the barrel region is in a shape that is not circular, thegap can take the shape of the inner surface of the barrel region suchthat, when the applicator and the pessary device share a common centrallongitudinal axis, the pessary device outer surface does not contact thebarrel region inner surface. The annular gap can be, for example, 0.01mm to 3 mm, 0.1 mm to 2 mm, 0.5 mm to 1 mm, such as for example 0.2 mm,0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.1 mm, 1.2 mm,1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm,2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm.

The relationship between the outer circumference of the pessary deviceand the inner circumference of the applicator barrel region can comprisea ratio of between 0.3:1 to 0.99:1, such as, for example, 0.35:1, 0.4:1,0.45:1, 0.5:1, 0.55:1, 0.6:1, 0.65:1, 0.7:1, 0.75:1, 0.8:1, 0.85:1,0.9:1, 0.91:1, 0.92:1, 0.93:1, 0.94:1, 0.95:1, 0.96:1, 0.97:1, or0.98:1.

The combination of the applicator and the pessary device has a maximumexpulsion force of less than 2000 grams-force, such as, for example,between 0 and 1,500 grams-force, between 100 grams-force and 1,000grams-force, between 200 grams-force and 800 grams-force, between 300grams-force and 750 grams-force, between 350 grams-force and 600grams-force, between 400 grams-force and 500 grams-force.

It has been found that the expulsion force needed to insert the pessarydevice is actually the sum of a frictional force created by the pessarydevice contacting the inner surface of the applicator barrel region, theforce needed to offset the weight of the pessary device due to gravity,and the force needed to open the petals or potential restriction thatmaintains the pessary device in the applicator.

Creating a desirable usage experience during insertion representsreducing the expulsion force to increase the ease of insertion. A largecomponent of the expulsion force is frictional force. Applicants havefound that the normal force can be reduced or made negligible bycreating a gap between the applicator barrel region and the pessarydevice, thereby lowering the frictional force. The annular gap is formedby a barrel region diameter that is larger than the largest diameter ofthe non-expandable pessary device. Further, by minimizing the normalforce, it has been surprisingly found that one can utilize thin wallsfor the applicator. This is unlike an applicator that is used with anexpanding pessary device which may require walls thick enough towithstand any pressures exerted by the expanding device.

TABLE 1 Maximum Expulsion Force Using Tensile Tester for Pessary Devicesusing Applicators Product Average Maximum Expulsion Force (g) CommercialPessary 1 1352 Commercial Pessary 2 1387 Invention A 285 Tampax Ultra293

It has also been found that, by using a lightweight pessary device, onecan offset the normal force and force of gravity to create combinedapplicator and pessary device with an expulsion force that is in linewith light weight tampons instead of traditional pessary devices. Ingeneral, the maximum expulsion force for tampons typically range from200 grams-force to 800 grams-force. The maximum expulsion force is ameasure of the highest force needed in the process of expelling a devicefrom the applicator.

The proposed combined pessary device and applicator requires less workto expel the pessary device from the applicator. As shown in Table 2below, the work required to expel the pessary device can be less thanthe work required to expel a tampon.

Product Average Work to Expel Device (N*mm) Invention A 925 Tampax Ultra1105 Commercial Pessary 1 2177 Commercial Pessary 2 2111

As shown in FIGS. 6-8, the expulsion force profile of Invention A (FIG.6) has a two peak structure wherein neither peak exceeds 4 newtons, thesecond peak is a percentage of the first peak, and the area between thetwo peaks drops to nearly zero newtons. Comparing the expulsion forceprofile of FIG. 6 to that of a tampon (FIG. 7), it is noted that bothhave a similar max peak force of less than 5 newtons. However, unlikethe tampon expulsion force profile which gradually decreases after theinitial peak, Invention A has an expulsion force profile that drops tonearly zero for a large portion of the device. This allows Invention Ato have a lower total work requirement versus the tampon.

As shown in FIG. 8, the commercial pessary expulsion force profile hasmultiple peaks. The first peak and the second peak both exceed 5 N. Inaddition to the two first peaks, there are two more inflection points inthe slope of the force profile where the force required increasescreating a four peak profile wherein at least the first two peaks areabove 5 newtons. In comparison to both the tampon and Invention A, thecommercial pessary is both harder to expel, requiring more force as onemoves through the expulsion process, and more overall work to expel thedevice as seen in Table 2.

The insertion member and/or plunger can be constructed from any suitablematerial. Suitable materials include, for example, paper, paperboard,cardboard, cellulose, such as, e.g., molded cellulose, or anycombinations thereof, polyethylene, polypropylene, polybutylene,polystyrene, polyvinylchloride, polyacrylate, polymethacrylate,polyacrylonitrile, polyacrylamide, polyamide, nylon, polyimide,polyester, polycarbonate, polylactic acid, poly hydroxyalkanoate,ethylene vinyl acetate, polyurethane, silicone, derivatives thereof,copolymers thereof, mixtures thereof, or any suitable smooth plasticmaterial. Examples of suitable materials are disclosed in, e.g., U.S.Pat. Nos. 5,346,468 and 5,558,631. Additives can be included in thematerial to alter or enhance certain material properties. Suitableadditives include, for example, mold release agents, slip agents,surface energy modifiers, pearlescent agents, and/or any other suitableadditives. The insertion member also or alternatively can be coated witha substance to give it a high slip characteristic, such as, e.g., withwax, polyethylene, a combination of wax and polyethylene, cellophane,clay, mica, and other lubricants that can facilitate comfortableinsertion. Alternatively, or in addition, the insertion member caninclude a textured surface. Texture can be provided in any suitablemanner, such as, e.g., by designing texture into or adding texture tothe insertion member.

The applicator walls can be between 0.1 mm and 2 mm, such as, forexample, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm,or 1.0 mm.

The barrel portion of the applicator can be sized and configured tohouse a feminine hygiene product, such as, e.g., an absorbent tamponand/or pessary. The size of the barrel portion can be determinedprimarily by the dimensions of the feminine hygiene product. Forexample, the barrel portion can have inner diameters of about 5.0millimeters to about 22.0 millimeters and a wall thickness of about 0.1millimeter to about 2.0 millimeters. The inner diameter of the barrelportion can be greater than the diameter of the feminine hygiene productto prevent the barrel portion from interfering with the expulsion of thefeminine hygiene product from the barrel portion. The inner diameter ofthe barrel portion can have varying diameters and shapes to conform tothe profiled shape of the enclosed feminine hygiene product, such as,e.g., a pessary. The barrel portion can have a length sufficient tohouse the feminine hygiene product prior to the expulsion of thefeminine hygiene product from the applicator into the vagina.

The barrel portion can be of any suitable cross-sectional shape. Thebarrel portion can include a generally non-circular cross-sectionalshape, such as, e.g., oval, rectangular, elliptical, oblate, or othersuitable shapes. The barrel portion can have a cross-sectional shapethat has a greater thickness than width or vice versa. The barrelportion can have a substantially uniform cross-section, such as, e.g.,having the same cross-section along the length. The barrel portion canhave varying cross-sectional shapes and/or cross-sectional sizes, suchas, e.g., a barrel portion having a smaller cross-sectional area nearthe insertion end of the barrel and a larger cross-sectional area nearthe opposite end.

The insertion end of the barrel portion can be open-end or closed-ended.The insertion end of the barrel portion can include petals,corrugations, pleats, a film cap, or other means for covering the barrelportion prior to expulsion of the tampon. In certain embodiments, thematerial, such as, e.g., a feminine care product can be loaded into thebarrel portion prior to covering the insertion end of the barrelportion. Alternatively, the insertion end of the barrel portion can becovered prior to loading the feminine hygiene product into the barrelportion.

The insertion end can have at least one containing element. Thecontaining element maintains the pessary device within the applicatoruntil it is expelled by a user. The containing element can be, forexample, a petal, a plurality of petals, a strip of material thatobstructs the barrel region insertion end, and a cap attached to thebarrel region. The containing element can be integral to the applicatoror attached to the applicator. The containing element can be made from adifferent material than the applicator such as, for example, a film. Thefilm can be made of one or more of the following substrates and resins:polyolefins, cellulose materials and derivatives, including celluloseethers, ethyl and/or methyl celluloses, cellulose esters, celluloseacetates, and/or formates, vinyl polymer derivatives, or more typicallycellophane and/or polyethylenes, polypropylenes, PET, PVC, latex, nylon,polyesters, polystyrenes. Some other resins and films includepolylactides, polyester amides, aliphatic esters, aliphatic-aromaticcopolyesters, polyhydroxyalkonoates, polyalkulene succinate, polyvinylalcohols, cellulosic polymers, starch-based materials and/orpolycaprolactone. Polyolefin, such as polyethylenes and polypropylenesand/or biodegradable films are typical.

The containing element can be a film cap as disclosed in U.S. Pat. No.6,958,057. The film cap can be made of any type of planar, flexible filmor other deformable substrate. The typical film material used to make afilm cap can be a sheet-shaped substrate that can smooth or embossed.Some materials include paper, woven and non-woven substrates, cloths,metal foils, cellulose fiber sheets, and organic polymeric materials.

The insertion member can include a grip region, such as, for example, anindentation region. The grip region can have a plurality ofthree-dimensional surface elements, such as, e.g., projections, rings,ridges, ribs, embossments, depressions, grooves, and/or other grippingstructures. The three-dimensional surface elements can be provided inany suitable manner, such as, e.g., by the addition of material, and/orby impressing, such as, e.g., by embossing, or compressing the surfaces.For example, the indentation region can include one or more flattenedsides and/or one or more spaces for a decorative marking or a character,such as, e.g., an embossed and/or printed marking or character. Inaddition, or alternatively, the surfaces of the indentation region caninclude a material that can provide a frictional resistance for theuser's fingers during the insertion of the applicator into the body.Suitable materials that can provide friction include, for example,abrasive materials, high wet coefficient of friction materials, pressuresensitive adhesives, or any combinations thereof.

The gripping indicia can communicate to a user where the grip portion islocated on the applicator, which can assist the user in proper placementof her fingers on the grip portion and/or can increase the user'sconfidence in proper handling of the applicator. In addition, oralternatively, the gripping indicia can communicate to a user theidentity and/or absorbency of material disposed within the applicator,can indicate to a user when the applicator is fully inserted, and/or canincrease user enjoyment. The gripping indicia can show a user how toproperly orient an applicator, such as, e.g., an applicator having anon-circular cross-sectional shape and/or an applicator containingmaterial with more expansion in a direction, such as, e.g., width-wiseexpansion.

The visual indicia can also be a pattern, such as, e.g., a printed,molded, adhered, hot stamped, screen printed, pressure sensitive label,therimage label, shrink sleeve, and/or painted pattern. The visualindicia can be a line or can provide the perception of a line, such as,e.g., a colored line, a patterned line, a broken line, or a foil line,that can be positioned to provide a gripping indicia, such as, e.g., todemarcate the grip portion from the barrel portion and/or the plungerportion.

The gripping indicia can be tactile indicia. Any tactile indiciasuitable from distinguishing the grip portion from the barrel portionand/or the plunger can be used, such as, e.g., textures, embossments,raised printing, compressible material, such as, e.g., rubber, silicone,and/or foam, and/or other material that can increase the coefficient offriction of the grip portion. The tactile indicia can be a generallyuniform texture, such as, e.g., a coating or additive applied to thegrip portion, as compared to a generally discontinuous texture, such as,e.g., a series of ribs, ridges, or raised portions. Tactile indicia can,for example, distinguish the grip portion from the barrel portion and/orthe plunger and/or can provide the user with improved applicator controland decreased finger slippage.

The gripping indicia can be made in any suitable manner, such as, e.g.,by printing, stamping, embossing, injection molding, reforming, such as,e.g., via heat, dipping, such as, e.g., in a liquid solution,co-injection molding, taping, adhering, painting, screen printing,pressure sensitive labeling, hot stamping, therimage labeling, shrinksleeve, dimensional coating, combinations thereof, and/or any othersuitable manner.

The grip portion can be constructed from any suitable material. Thebarrel portion can be constructed from any suitable material. Suitablematerials include, for example, paper, paperboard, cardboard, cellulose,such as, e.g., molded cellulose, or any combinations thereof,polyethylene, polypropylene, polybutylene, polystyrene,polyvinylchloride, polyacrylate, polymethacrylate, polyacrylonitrile,polyacrylamide, polyamide, nylon, polyimide, polyester, polycarbonate,polylactic acid, polyhydroxyalkanoate, ethylene vinyl acetate,polyurethane, silicone, thermoplastic starch, trans-poly isoprene,derivatives thereof, copolymers thereof, mixtures thereof, or anysuitable smooth plastic material. Additives can be included in thematerial to alter or enhance certain material properties. Suitableadditives include, for example, mold release agents, slip agents,surface energy modifiers, pearlescent agents, inorganic fillers, and/orany other suitable additives. The grip portion can be a same material asthe barrel portion. Alternatively, the grip portion can be one or moredifferent materials as compared to the barrel portion. The grip portioncan also comprise one or more compressible materials, such as, e.g.,rubber, silicone, and/or foam, and/or one or more soft plastics. Thegrip portion can have a substantially rigid inner surface and adeformable outer surface, such as, e.g., to improve user comfort whilesubstantially preventing compression of the interior of the grip, suchas, e.g., to allow the plunger to move in the axial direction while theouter surface of the grip is deformed by a user's fingers.

The plunger can be constructed from any suitable material. The barrelportion can be constructed from any suitable material. Suitablematerials include, for example, paper, paperboard, cardboard, cellulose,such as, e.g., molded cellulose, or any combinations thereof,polyethylene, polypropylene, polybutylene, polystyrene,polyvinylchloride, polyacrylate, polymethacrylate, polyacrylonitrile,polyacrylamide, polyamide, nylon, polyimide, polyester, polycarbonate,polylactic acid, polyhydroxyalkanoate, ethylene vinyl acetate,polyurethane, silicone, thermoplastic starch, trans-poly isoprene,derivatives thereof, copolymers thereof, mixtures thereof, or anysuitable smooth plastic material. Suitable plungers are disclosed in,e.g., U.S. Pat. No. 5,346,468 and U.S. Pat. No. 5,558,631. Additives canbe included in the material to alter or enhance certain materialproperties. Suitable additives include, for example, mold releaseagents, slip agents, surface energy modifiers, pearlescent agents,inorganic fillers, and/or any other suitable additives.

The plunger can be hollow or solid. The plunger can have a hollowinterior, a first end, and a second end opposed to the first end. Thefirst end is the portion of the plunger that pushes against the tamponduring the expulsion of the tampon from the barrel portion. The secondend is the portion of the plunger in which the axial force is applied toexpel the tampon from the barrel portion. The plunger can have a lockingmechanism, such as, e.g., a locking mechanism that retains the plungerwithin the barrel portion and/or grip portion of the applicator prior todepression of the plunger and expulsion of the tampon. Examples of suchlocking mechanisms are described in, for example, U.S. Pat. Nos.6,019,744 and 6,450,986.

The plunger can be an optional component for use with the applicator.For example, the applicator can be fully functional if the plunger isomitted, i.e., if a user must insert and push the feminine hygieneproduct through the tampon applicator digitally.

At least a portion of the applicator can contact and/or conform to atleast a portion of the surface of the tampon. Rigid insertion endstructures can be shaped in a suitable manner, such as, e.g., byinjection molding, or by reshaping in a secondary process to provide atleast a degree of profiled shape observation. Alternatively, insertionends of applicators made from flexible or pliable materials, such asfilms, paper and flexible wovens or non-wovens, can also be used. Suchflexible or pliable insertion ends include those which partially orfully enclose the tampon comprising a “sleeve” or a “tube,” such as,e.g., in U.S. Pat. Nos. 2,922,422 and 2,922,423; a “sheath,” such as,e.g., in U.S. Pat. Nos. 2,092,427 and 3,749,093; a “barrel,” such as,e.g., in U.S. Pat. No. 5,135,475; a “bag,” such as, e.g., in U.S. Pat.No. 3,358,686; or a “film enclosure,” such as, e.g., in U.S. Pat. No.4,610,659.

FIG. 9 shows a partial cross-section of an applicator barrel. Theapplicator barrel 50 includes an insertion tip 52 proximal a first end53. A plurality of petals 54 is disposed about insertion tip 52. A slot55 exists between adjacent petals. Each of petals 54 has a petal base 56and a petal length PL extending from petal base 56 to the petal distalend 57. Insertion tip 52 has a tip length TL defined from a point 5 mmbelow petal bases 56 and extending to petal distal ends 57.

Insertion tip 52 has a tapering wall thickness along tip length TLdefined by angle α. Some commercially-available applicators include adraft angle to aid in removing the applicator from a manufacturing mold,but these angles are generally small; for example, around 0.2 degrees. Awall thickness angle α in insertion tip 52 can be at least twice such adraft angle. For example, insertion tip 52 along tip length TL can havea wall thickness angle α of greater than or equal to 0.4 degrees, 0.5degrees, 0.6 degrees, 0.7 degrees, 0.8 degrees, 1 degree, 2 degrees ormore. Other wall thickness angles are contemplated by the presentinvention, even though they are not explicitly mentioned.

The insertion tip may comprise more than one angle. That is, theinsertion tip may have a non-uniform taper along the tip length. Forexample and with reference to FIG. 5, applicator barrel 60 includes aninsertion tip 62 that comprises a first angle β and a second, differentangle λ along different sections of tip length TL. The two angles candiffer in dimension from one another by 50% or more. The first angle βcan be less than or equal to 0.3 degrees and second angle λ is greaterthan or equal to 0.4 degrees.

As noted in the background section, known applicator petals generallybend at the petal bases. Unique design approaches of the presentinvention permit the creation of one or more inflection or bendingpoints at locations other than the petal bases. The design approachesprovided by the present invention reduce and/or increase flexuralresistance in targeted regions of the insertion tip. The wall thicknessof the insertion tip can vary by at least 15%, 20%, or 25% over a 3 mm,4 mm, or 5 mm section along the tip length to create a petal dominginflection point. This creates a step change in wall thickness. Athickness step change can be imparted via a single wall thickness anglewith surrounding sections being devoid of a wall thickness taper, or viatwo or more angles. Petal inflection points of the present invention canexist proximal the petal bases. Petal inflection points can exist abovethe petal bases; for example, at least 1 mm, at least 2 mm, or at least3 mm above the petal bases. Petal wall thickness can also varycircumferentially along the width of the petals.

Pessary Expulsion Force Test

The expulsion force can be measured by using a Pessary Expulsion ForceTest. The Pessary Expulsion Force Test determines the forcecharacteristics of pessary expulsion from an applicator. The test canutilize a constant rate of elongation tensile tester with a load cellchosen such that the measure force is between 10% and 90% of the cell'scapacity. The test can also utilize an applicator fixture that must beable to hold applicator vertically downward (petals facing down) whileexerting minimal force to the axial portion of the applicator.

The tester and fixture is placed in a room with a temperature of 21° C.(±4° C.). This uniform temperature allows for comparison betweenproducts that expand based on temperature.

Sample Preparation (if Needed):

A test sample is prepared by removing any outer wrapper that may existand tucking any out-hanging withdrawal cord inside the applicatorpusher.

The applicator is placed into fixture such that the lip of theapplicator is being held up (opposite to the direction of testing,preventing applicator from falling through the fixture). The fixture isthen oriented within the tensile tester setup such that the direction ofthe force of the tensile tester should follow the long direction of theapplicator and be applied directly on the pusher (plunger). The test isthen run (speed: 1 mm/sec, data acquisition 20 hz) where the tensiletester is exerting downward force directly on the pusher such that thepessary moves toward and out of the petals. Test is complete when thebody of the pessary has been completely expelled from the applicator.

Reporting of the results includes obtaining the force vs extensioncurves and determining the maximum expulsion force, as well as thenumber of peaks in the curve, at what displacements they occurred andthe corresponding loads. Examples of reported results are found on FIGS.6-8.

The pessary device can be used daily. For example, a user can insert thepessary device, wear the pessary device for a suitable wear time, suchas, for example, up to 4 hours, up to 5 hours, up to 6 hours, up to 7hours, up to 8 hours, up to 9 hours, up to 10 hours, up to 11 hours, orup to 12 hours, or more, remove the pessary device, dispose of thepessary device, and insert a new pessary device.

The dimensions and values disclosed herein are not to be understood asbeing strictly limited to the exact numerical values recited. Instead,unless otherwise specified, each such dimension is intended to mean boththe recited value and a functionally equivalent range surrounding thatvalue. For example, a dimension disclosed as “40 mm” is intended to mean“about 40 mm.”

Values disclosed herein as ends of ranges are not to be understood asbeing strictly limited to the exact numerical values recited. Instead,unless otherwise specified, each numerical range is intended to meanboth the recited values and any integers within the range. For example,a range disclosed as “1 to 10” is intended to mean “1, 2, 3, 4, 5, 6, 7,8, 9, and 10.”

All documents cited in the Detailed Description of the Invention are, inrelevant part, incorporated herein by reference; the citation of anydocument is not to be construed as an admission that it is prior artwith respect to the present invention. To the extent that any meaning ordefinition of a term in this document conflicts with any meaning ordefinition of the same term in a document incorporated by reference, themeaning or definition assigned to that term in this document shallgovern.

While particular embodiments of the present invention have beenillustrated and described, it would be obvious to those skilled in theart that various other changes and modifications can be made withoutdeparting from the spirit and scope of the invention. It is thereforeintended to cover in the appended claims all such changes andmodifications that are within the scope of this invention.

What is claimed is:
 1. An epicardial clip for placement on theepicardial surface of An intravaginal pessary device housed within anapplicator, the device having an outer periphery defining a total areaof the device, a top portion having a top lateral dimension, a bottomportion having a bottom lateral dimension and a midsection between thetop portion and the bottom portion and having a midsection lateraldimension, wherein each of the top portion lateral dimension and bottomlateral dimension are greater than the midsection lateral dimension, andthe applicator comprises a barrel region with an insertion endcomprising a containment element comprising at least one petal, whereinthe pessary device has a greatest outer lateral dimension and the barrelregion of the applicator has a greater inner lateral dimension, and thegreatest inner lateral dimension is greater than the greatest outerlateral dimension, wherein the pessary device and the applicator exhibita maximum expulsion force that is greater than 0 and less than 1500grams-force, and wherein the pessary device and applicator exhibit anexpulsion force profile that has a two peak structure with a first peakoccurring proximate commencement of application of expulsion force, asecond peak occurring proximate completion of the application of theexpulsion force, wherein the first and second peaks are the highest twopeaks of the force profile, neither peak exceeds 4 Newtons, the secondpeak is a percentage of the first peak, and the area between the twopeaks drops to below 2 Newtons.
 2. The pessary device and applicator ofclaim 1, wherein the pessary device has a maximum diameter and a minimumdiameter, and wherein the minimum diameter is located in a centralregion.
 3. The pessary device and applicator of claim 1, wherein pessarydevice has a length between 35 mm and 60 mm and the maximum diameter isgreater than 10 mm and less than 35 mm.
 4. The pessary device andapplicator of claim 1, wherein the pessary device has a weight greaterthan 1 gram and less than 10 grams.
 5. The pessary device and applicatorof claim 1, wherein the applicator wall has a thickness greater than0.01 mm and less than 1 mm.
 6. The pessary device and applicator ofclaim 1, wherein the pessary device has an outer circumference and thebarrel region of the applicator has an inner circumference, and a ratioof the outer circumference to the inner circumference is greater than0.3:1 and less than 0.99:1.
 7. The pessary device and applicator ofclaim 1, wherein the pessary device and applicator require greater than0 Newtons per mm and less than 1000 Newtons per mm average to expel thepessary device.
 8. The pessary device and applicator of claim 1, furthercomprising an inner diameter of the applicator barrel, wherein the innerdiameter of the applicator barrel is greater than 5 mm and less than 22mm in diameter.
 9. The pessary device and applicator of claim 1, whereinthe pessary device is in the shape of an hourglass, a waisted cylinder,a figure-8 or a peanut.
 10. The pessary device and applicator of claim1, wherein the pessary device comprises a convex portion and a concaveportion, and wherein the convex portion provides more resistance toforce than the concave portion.